Vertex submits NDA to FDA for triple combination regimen of VX-445 in cystic fibrosis
Vertex announced submission of a NDA to the FDA for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen. The NDA includes a request for Priority Review, which, if granted, would shorten the FDA’s review of the NDA to eight months from the time of submission. July 22, 2019